[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100341897":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":84,"studyPopulation":77,"armGroups":85,"interventions":97,"overallOfficials":105,"centralContacts":110,"locations":117,"responsibleParty":250,"collaborators":252,"id":268,"slug":77,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":77,"eligibilityCriteria":273,"healthyVolunteers":269,"sex":274,"minAge":275,"maxAge":77,"enrollmentInfo":276,"targetDuration":77,"studyType":279,"phases":280,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":120,"whyStopped":77,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"The HIV Netherlands Australia Thailand Research Collaboration","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":77},[9],{"measure":10,"description":11,"timeFrame":12},"proportion of subjects from the ITT analysis population with plasma HIV-1 RNA \u003C50 c\u002FmL at Week 24","The primary efficacy endpoint is the proportion of subjects from the ITT analysis population with plasma HIV-1 RNA \\\u003C50 c\u002FmL at Week 24.","Week 24",[14,17,19,21,23,26,29,33,35,37,39,41,44,47,50,53,56,59,62,64,68,71,74],{"measure":15,"description":15,"timeFrame":16},"AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID","Week 4",{"measure":18,"description":18,"timeFrame":16},"Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID",{"measure":20,"description":20,"timeFrame":16},"Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID",{"measure":22,"description":22,"timeFrame":16},"Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID",{"measure":24,"description":25,"timeFrame":12},"Proportion of subjects with plasma HIV-1 RNA \u003C50 c\u002FmL at Week 24","Proportion of subjects with plasma HIV-1 RNA \\\u003C50 c\u002FmL at Week 24",{"measure":27,"description":27,"timeFrame":28},"Changes in CD4+ counts from baseline to Week 24 and Week 48","Weeks 24 and 48",{"measure":30,"description":31,"timeFrame":32},"Incidence of disease progression","Incidence of disease progression (HIV-associated conditions, new AIDS diagnoses, and death)","Week 48",{"measure":34,"description":34,"timeFrame":32},"Proportion of subjects that have completed TB treatment",{"measure":36,"description":36,"timeFrame":32},"Proportion of subjects that are cured from TB",{"measure":38,"description":38,"timeFrame":32},"Proportion of subjects that have relapsed",{"measure":40,"description":40,"timeFrame":32},"Proportion of subjects that have defaulted",{"measure":42,"description":43,"timeFrame":32},"TB outcome in terms of cure","Number of participants that have been cured of TB",{"measure":45,"description":46,"timeFrame":32},"TB outcome in terms of relapse","Number of participants with relapse",{"measure":48,"description":49,"timeFrame":32},"TB outcome in terms of treatment failure due to TB resistance","Number of participants with treatment failure due to TB resistance",{"measure":51,"description":52,"timeFrame":32},"TB outcome in terms of incidence","Incidence of all AEs, SAEs, and laboratory abnormalities",{"measure":54,"description":55,"timeFrame":32},"TB outcome in terms of severity","Severity of all AEs, SAEs, and laboratory abnormalities",{"measure":57,"description":58,"timeFrame":32},"discontinuation from the study","Proportion of subjects who permanently discontinued randomization arm due to AEs or death",{"measure":60,"description":61,"timeFrame":32},"discontinuation from the study drugs","Proportion of subjects who temporarily discontinued the study drugs and\u002For TB therapy due to AEs",{"measure":63,"description":63,"timeFrame":32},"Proportion of subjects with TB-associated IRIS",{"measure":65,"description":66,"timeFrame":67},"AUC of DTG at Weeks 4 (with RIF) and 48 (without RIF)","AUC of DTG at Weeks 4 (with RIF) and 48 (without RIF) will be analyzed using population PK modeling approach to estimate AUC","Weeks 4 and 48",{"measure":69,"description":70,"timeFrame":67},"Cmax of DTG at Weeks 4 (with RIF) and 48 (without RIF)","Cmax of DTG at Weeks 4 (with RIF) and 48 (without RIF) will be analyzed using population PK modeling approach to estimate Cmax",{"measure":72,"description":73,"timeFrame":67},"Ctrough of DTG at Weeks 4 (with RIF) and 48 (without RIF)","Ctrough of DTG at Weeks 4 (with RIF) and 48 (without RIF) will be analyzed using population PK modeling approach to estimate Ctrough",{"measure":75,"description":76,"timeFrame":32},"proportion of subjects with plasma HIV-1 RNA \u003C50 c\u002FmL at Week 48","proportion of subjects with plasma HIV-1 RNA \\\u003C50 c\u002FmL at Week 48 (viral suppression)",null,{"allocation":79,"interventionModel":80,"interventionModelDescription":77,"primaryPurpose":81,"observationalModel":77,"timePerspective":77,"maskingInfo":82},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":83,"maskingDescription":77,"whoMasked":77},"NONE","This is a Stage II, randomized, open-label study describing the efficacy and safety of DTG 50 mg OD with food and DTG 50 mg BID plus 2NRTIs in HIV\u002FTB co-infected patients receiving RIF based anti-TB therapy. The study will be conducted in approximately 200 HIV-1 infected individuals who are ART-naïve and newly diagnosed with probable or confirmed pulmonary, pleural, or lymph node (LN) Mycobacterium TB (MTB) taking RIF-containing first-line TB treatment. Subjects should have confirmed RIF-sensitive MTB infection as determined by GeneXpert (or equivalent approved molecular test) or mycobacterial culture.\n\nThe study is comprised two different stages:\n\n1. Stage1, investigators will test the safety and tolerability, as well as Pharmacokinetics (PK), of two different doses of dolutegravir co-administered with standard anti-TB treatment. Overall, 40 HIV\u002FTB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). Intensive PK of DTG will be performed at week 4. Interim analysis will be performed if all 40 cases completed 12 weeks and 24 weeks. Premature study termination will be set for\n\n   1. proportion of HIV RNA \\\u003C 50 copies\u002Fml at week 24 between 2 group is different \\> 20%\n   2. DTG 50 mg with food has geometric mean DTG Ctrough \\\u003C 0.3 mg\u002FL If there is no premature study termination met, the study will move to stage 2. Stage 2 will only be recruited if two different doses of dolutegravir are well tolerated and safe.\n2. Stage 2: 160 HIV\u002FTB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). DTG concentration will be performed at week 4 and 48. Interim analysis will be performed if all 200 cases completed 24 weeks.",[86,92],{"label":87,"type":88,"description":89,"interventionNames":90},"DTG 50 mg OD with food","ACTIVE_COMPARATOR","DTG 50 mg OD with food plus 2NRTIs in HIV\u002FTB co-infected patients receiving RIF based anti-TB therapy.",[91],"Drug: DTG 50 mg OD with food",{"label":93,"type":88,"description":94,"interventionNames":95},"DTG 50 mg BID","DTG 50 mg BID plus 2NRTIs in HIV\u002FTB co-infected patients receiving RIF based anti-TB therapy.",[96],"Drug: DTG 50 mg BID",[98,102],{"type":99,"name":87,"description":100,"armGroupLabels":101,"otherNames":77},"DRUG","Dolutegravir 50 mg once daily with food plus 2NRTIs in HIV\u002FTB co-infected patients receiving RIF based anti-TB therapy",[87],{"type":99,"name":93,"description":103,"armGroupLabels":104,"otherNames":77},"Dolutegravir 50 mg BID plus 2NRTIs in HIV\u002FTB co-infected patients receiving RIF based anti-TB therapy.",[93],[106],{"name":107,"affiliation":108,"role":109},"Anchalee Avihingsanon, MD, PhD","Thai Red Cross AIDS Research Centre","PRINCIPAL_INVESTIGATOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":115,"email":116},"June Ohata, BS","CONTACT","6626523040","147","juneohata4@gmail.com",[118,134,145,159,170,183,198,211,224,234],{"facility":119,"status":120,"city":121,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":131},"Klang Hospital","RECRUITING","Bangkok","10100","Thailand","TH",{"type":126,"coordinates":127},"Point",[128,129],100.50144,13.75398,{"lat":129,"lon":128},[132],{"name":133,"role":113,"phone":77,"phoneExt":77,"email":77},"Praniti Danpornprasert, MD",{"facility":135,"status":120,"city":121,"state":121,"zip":136,"country":123,"countryCode":124,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"Bhumibol Adulyadej Hospital","10220",{"type":126,"coordinates":138},[128,129],{"lat":129,"lon":128},[141,144],{"name":142,"role":113,"phone":77,"phoneExt":77,"email":143},"Chris Fujitnirun, MD","fujitnirunchris@gmail.com",{"name":142,"role":113,"phone":77,"phoneExt":77,"email":77},{"facility":146,"status":120,"city":121,"state":121,"zip":147,"country":123,"countryCode":124,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Infectious Disease, Chulalongkorn University","10330",{"type":126,"coordinates":149},[128,129],{"lat":129,"lon":128},[152,155,157],{"name":153,"role":113,"phone":77,"phoneExt":77,"email":154},"Gompol Suwanpimolkul, MD","sgompol@gmail.com",{"name":156,"role":113,"phone":77,"phoneExt":77,"email":77},"Gompol Suwanpimolkul",{"name":158,"role":113,"phone":77,"phoneExt":77,"email":77},"Opass Putcharoen",{"facility":160,"status":120,"city":121,"state":121,"zip":161,"country":123,"countryCode":124,"cosmosGeoPoint":162,"geoPoint":164,"contacts":165},"Infectious Disease Taksin Hospital","10600",{"type":126,"coordinates":163},[128,129],{"lat":129,"lon":128},[166,169],{"name":167,"role":113,"phone":77,"phoneExt":77,"email":168},"Supannee Jirajariyavet, MD","jsupunee@yahoo.com",{"name":167,"role":113,"phone":77,"phoneExt":77,"email":77},{"facility":171,"status":120,"city":172,"state":173,"zip":174,"country":123,"countryCode":124,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Infectious Disease Chonburi Hospital","Chon Buri","Changwat Chon Buri","20000",{"type":126,"coordinates":176},[177,178],100.98345,13.3622,{"lat":178,"lon":177},[181],{"name":182,"role":113,"phone":77,"phoneExt":77,"email":77},"Palakorn Panarat, MD",{"facility":184,"status":120,"city":185,"state":186,"zip":187,"country":123,"countryCode":124,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Bamrasnaradura Infectious Diseases Institute","Nonthaburi","Changwat Nonthaburi","11000",{"type":126,"coordinates":189},[190,191],100.51477,13.86075,{"lat":191,"lon":190},[194,197],{"name":195,"role":113,"phone":77,"phoneExt":77,"email":196},"Weerawat Manosuthi, MD","drweerawat@hotmail.com",{"name":195,"role":113,"phone":77,"phoneExt":77,"email":77},{"facility":199,"status":120,"city":200,"state":201,"zip":202,"country":123,"countryCode":124,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Infectious Disease Buddhachinaraj Phitsanulok Hospital","Phitsanulok","Changwat Phitsanulok","65000",{"type":126,"coordinates":204},[205,206],100.25858,16.82481,{"lat":206,"lon":205},[209],{"name":210,"role":113,"phone":77,"phoneExt":77,"email":77},"Pornpit Treebupachatsakul, MD",{"facility":212,"status":120,"city":213,"state":214,"zip":215,"country":123,"countryCode":124,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Infectious Disease Chiangrai Prachanukroh Hospital","Chiang Rai","Chiangrai","57000",{"type":126,"coordinates":217},[218,219],99.8325,19.90858,{"lat":219,"lon":218},[222],{"name":223,"role":113,"phone":77,"phoneExt":77,"email":77},"Suwimol Khusuwan, MD",{"facility":225,"status":120,"city":121,"state":77,"zip":147,"country":123,"countryCode":124,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"Chest Division, Faculty of Medicine, Chulalongkorn University",{"type":126,"coordinates":227},[128,129],{"lat":129,"lon":128},[230,233],{"name":231,"role":113,"phone":77,"phoneExt":77,"email":232},"Kamol Kawkitinarong, MD","kamonkaw@hotmail.com",{"name":231,"role":113,"phone":77,"phoneExt":77,"email":77},{"facility":235,"status":120,"city":121,"state":77,"zip":147,"country":123,"countryCode":124,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"HIV-NAT, Thai Red Cross - AIDS Research Centre",{"type":126,"coordinates":237},[128,129],{"lat":129,"lon":128},[240,243,244,246,248],{"name":107,"role":113,"phone":241,"phoneExt":77,"email":242},"662 652 3040","anchalee.a@hivnat.org",{"name":107,"role":113,"phone":77,"phoneExt":77,"email":77},{"name":245,"role":113,"phone":77,"phoneExt":77,"email":77},"Sivaporn Gatechompol, MD",{"name":247,"role":113,"phone":77,"phoneExt":77,"email":77},"Win Min Han, MD",{"name":249,"role":113,"phone":77,"phoneExt":77,"email":77},"Akarin Hiransuthikul, MD",{"type":251,"investigatorFullName":77,"investigatorTitle":77,"investigatorAffiliation":77,"oldNameTitle":77,"oldOrganization":77},"SPONSOR",[253,255,257,258,260,261,262,263,264,266],{"name":254,"class":6},"Chulalongkorn University",{"name":184,"class":256},"OTHER_GOV",{"name":135,"class":6},{"name":160,"class":259},"UNKNOWN",{"name":119,"class":259},{"name":212,"class":259},{"name":171,"class":259},{"name":199,"class":259},{"name":265,"class":6},"Radboud University Medical Center",{"name":267,"class":256},"Ministry of Health, Thailand","100341897",false,"NCT03731559","Efficacy, Safety and Pharmacokinetics of DTG with RIF","Efficacy, Safety and Pharmacokinetics of Dolutegravir 50 Mg Once Daily with Food Versus Dolutegravir 50 Mg Twice Daily in HIV\u002FTB Co-infected Patients Receiving Rifampin-based Antituberculosis Therapy","Inclusion Criteria:\n\n1. documented HIV positive\n2. Aged \\>18 years\n3. ARV naïve (previous exposure to ARV for \\\u003C 2 weeks)\n4. Any CD4 cell count\n5. ALT \\\u003C5 times ULN\n6. estimated GFR\\>60 ml\u002Fmin\u002F1.73m2\n7. Hemoglobin \\>7 mg\u002FL\n8. TB is diagnosed and there is a plan to receive stable doses of RIF containing anti-TB therapy for at least another 4 week period after initiation of ART\n9. No other active OI (CDC class C event) except oral candidiasis or disseminated MAC\n10. Body weight \\>40kg\n11. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and\u002For INIs\n2. Have previously treated for tuberculosis\n3. Currently using immunosuppressive agents.\n4. Currently using any prohibited medications that can affect the pharmacokinetics of the study drug such as phenobarbital, and carbamazepine\n5. Currently using alcohol or illicit substances that may affect the conduct of the trial as per the opinion of the site Principal Investigator\n6. Unlikely to be able to remain in the follow-up period as defined by the protocol\n7. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \\\u003C 5 x ULN.\n8. Have Karnofsky performance score \\\u003C30%\n9. Have TB meningitis, bone\u002Fjoints (due to prolonged use of anti-TB drug)\n10. Pregnant or breastfeeding","ALL","18 Years",{"count":277,"type":278},200,"ESTIMATED","INTERVENTIONAL",[281],"PHASE2","The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy. This Stage II trial will determine precisely the PK parameters of DTG in combination with RIF regimen in Thai HIV\u002FTB co-infected patients. After the optimal dose of DTG has been found, it will be further tested in a larger Stage III trial to assess its safety, tolerability and efficacy when used with RIF based regimen.",[284],"HIV\u002FTB Coinfection",[286,287,288,289,290,291],"Efficacy","safety","pharmacokinetics","Dolutegravir","HIV\u002FTB co-infected patients","rifampin-based antituberculosis therapy","2024-09-30",{"date":294,"type":295},"2024-10-02","ACTUAL",{"date":297,"type":295},"2019-06-25",{"date":299,"type":278},"2025-06-30",{"name":5,"class":6},10]